ANDA 075585

BAUSCH AND LOMB

FDA Drug Application

Application #075585

Documents

• Letter: 2000-12-21

Application Sponsors

ANDA 075585

BAUSCH AND LOMB

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

10MG/ML

0

CROMOLYN SODIUM

CROMOLYN SODIUM

FDA Submissions

	ORIG	1	AP	2000-12-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-10-09

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75585
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"CROMOLYN SODIUM","activeIngredients":"CROMOLYN SODIUM","strength":"10MG\/ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CROMOLYN SODIUM","submission":"CROMOLYN SODIUM","actionType":"10MG\/ML","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)